Supply Chain Updates

FDA Efforts to Increase Access and Supply of IV and PD Solutions: Hurricane Helene Recovery in North Carolina

FDA continues ongoing efforts to increase access to and supply of IV and peritoneal dialysis (PD) solutions following Hurricane Helene-related damage to Baxter International Inc.’s North Cove facility in Marion, North Carolina. Specifically, FDA acted quickly to conduct scientific and regulatory assessments, facilitating the temporary importation of 40 different IV and PD fluids from seven Baxter facilities around the world. These supply improvements, combined with increased output from other manufacturers, should help health care providers get more of the product they need over the coming weeks.

On October 28, FDA announced extended use dates for some parenteral drug products, after a review of the stability data submitted by Baxter International. Providers and patients that have the lot numbers in stock will be able to use them through the corresponding new use dates to help with supply. The following extended use dates are supported for specific lot numbers indicated in the linked table.

On October 11, FDA released immediately-in-effect guidance providing new flexibilities related to compounding of IV solutions to help fill the gaps from the impact of Hurricane Helene on Baxter's North Cove facility. This guidance will also make it easier for hospitals and other facilities to make their own IV solutions during the shortage.

HHS Informational Briefing on IV Fluid Conservation Best Practices (October 28, 2024)

An example of conservation strategies shared by one organization during the briefing. Video length is 36 minutes.

Hear from the Department of Health and Human Services, as well as hospital and group purchasing organization industry leaders, for an informational briefing on strategies to conserve intravenous fluid (IV) products that are in shortage and may be further impacted until Baxter’s North Cove, NC facility is operational.

Statement from Secretary Xavier Becerra on IV Fluid Increase (October 24, 2024)

“I am encouraged by reports that Baxter anticipates restarting the highest throughput manufacturing line at Baxter’s North Cove facility next week – sooner than originally expected. There’s more to do, including meeting regulatory requirements of the product manufactured on the restarted line, but this is good news for partners and patients..." 

Respiratory Illness Updates

Biden-Harris Administration Takes New Action to Halt the Spread of Bird Flu, including in California and Washington (October 24, 2024)

Since the first case of H5N1 was confirmed in cattle, USDA and HHS have led a whole-of-government approach to rapidly respond to the outbreak. In response to the recent spread of H5N1 in lactating dairy cows to California and the resulting human cases and the human cases in Washington resulting from an outbreak among poultry, the United States Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) are working closely with the state and local counterparts to respond to the outbreak and protect public health. While CDC’s assessment of the risk of avian influenza to the general public remains low, USDA and HHS continue to take this outbreak seriously to protect human health, animal health, and food safety. Read more.

Emergency Use Authorization (EUA) Updates

EUA Revisions and Updates Updated and Revised EUAs - Expiration Dates Extended iHealth Labs, Inc.: iHealth COVID-19/Flu A&B Rapid Test Lucira by Pfizer COVID-19 & Flu Test - Pfizer Inc. OSANG LLC: QuickFinder COVID-19/Flu Antigen Self Test OSANG LLC: OHC COVID-19/Flu Antigen Test Pro

Expiration date extension

• On October 18, 2024, FDA approved an extension to expiration for JYNNEOS final drug product lots FDP00017, FDP00018, FDP00019 and FDP00020 to August 31, 2026. Review the Dear Health Care Provider letter for additional instructions.

Quick Links

• Emergency Use Authorization - about EUAs, and links to current EUAs
• EUAs for Drugs and Non-Vaccine Biological Products (CDER)
• EUAs for Medical Devices (CDRH)
• COVID-19 Vaccines, including vaccine-specific pages with EUA info (CBER)
• COVID-19 Tests Granted Traditional Marketing Authorization by the FDA
• Emergency Use Authorization--Archived Information - EUAs that are no longer in effect because they have been terminated or revoked
• Historical Information about Device EUAs

Events

• November 7, 2024: 16th Annual Sentinel Initiative Public Workshop (Washington, DC or virtual)
• November 8, 2024: Informed Consent – More than Just Another Document to Sign? (virtual) - To provide patients and researchers with an overview of FDA’s expectations for informed consent.
• November 12, 2024: Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies (virtual) 
• November 12, 2024: FDA’s In Vitro Diagnostics (IVD) Roundtable – Fall Meeting (virtual) - Registration is required.
• November 17, 2024: 2024 FDA Broad Agency Announcement (BAA) Day (virtual) - Learn more about the agency-wide BAA for research and development to support regulatory science and innovation. Advance registration required.
• November 19, 2024: One Health Symposium "Paws, Claws, Hooves, Fins, and Feet: Advancements through a One Health Approach" (virtual)
• December 3, 2024: Registration & Listing Requirements for In Vitro Diagnostic Products (IVDs), Including Laboratory Developed Tests (LDTs) (virtual) - A webinar to provide information on how to comply with registration and listing requirements for IVDs, including LDTs.
• December 12, 2024: Vaccines and Related Biological Products Advisory Committee Meeting - The committee will discuss in open session considerations for RSV vaccine safety in pediatric populations.

In Case You Missed It

Many At-Home COVID-19 Tests Have Extended Expiration Dates

Tis the Season to Check, Confirm, and Test

Holiday celebrations are fast approaching. With an increase in social gatherings comes the likelihood of an increase in positive COVID-19 cases. Testing helps prevent and contain the spread of COVID-19 This holiday season, the FDA encourages you to check, confirm, and test.

Check the FDA’s website: Search the current list of authorized at-home COVID-19 tests because many have extended expiration dates.

Quick COVID-19 Resources Order free at-home tests at COVIDtests.gov Check expiration date extensions for your COVID-19 tests  Get the latest on COVID-19 vaccines Know your treatment options for COVID-19

Thanks for reading. This newsletter is produced by the FDA Office of Public Health Preparedness and Response, in the Office of the Chief Medical Officer (OCMO).